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Clinical oncology efficacy in hard-to-treat disease
TUB-040 generated clinically meaningful responses in heavily pretreated platinum-resistant ovarian cancer, according to reported findings. The update positions the candidate in a difficult line of...
Regulatory shift for overseas clinical trial oversight
The FDA said it will increase resources for foreign bioresearch monitoring (BIMO) inspections and update risk-based criteria used to select overseas clinical sites for audit. Acting Center for...
FDA accelerates early US trial starts
The FDA formally launched an expedited Investigational New Drug (IND) pilot under Operation Trialblazer to speed first-in-human timelines. The agency will select up to 10 qualified research...
Big biotech licensing and platform M&A—brain delivery
Novartis exercised an option to acquire full global rights to Sironax’s brain delivery platform for $125 million, while Sironax retains rights to develop selected assets using the technology. The...
Big Pharma dealmaking—bispecific screening engine
Roche struck a deal with Dualitas that includes $36.5 million upfront and could reach $1 billion total, funding the screening of more than 300,000 novel bispecific antibody combinations. The...
Biotech financings—oral drug phase 3 push
Sling Therapeutics closed a $123 million Series C to advance linsitinib, an oral thyroid eye disease (TED) candidate, through its Phase III confirmatory trial. The funding—led by Forbion with...
Clinical data—RNA splicing approach in Huntington’s
Skyhawk Therapeutics reported final results from a small study of once-daily SKY-0515, an RNA splicing pill for Huntington’s disease, showing symptom improvements at 15 months. In the trial,...
Platform/strategy—regulatory and commercialization for immune tolerance
RegCell raised $66 million to advance a Nobel Prize-linked immune tolerance platform, combining a fully subscribed $44 million Series A financing with a $22 million non-dilutive grant from Japan’s...
Next-gen genome engineering—precise large DNA integration
Researchers reported a new prime assembly approach in Nature that enables targeted genomic integration of long DNA fragments into programmable locations in living cells. The method uses...
Bispecific antibody discovery partnerships
Roche struck a deal with Dualitas to accelerate next-generation bispecific antibody discovery in inflammatory and immunology settings. The collaboration centers on high-throughput screening of...
Brain delivery platform deal
Novartis agreed to pay $125 million to secure global rights to Sironax’s blood-brain barrier crossing platform, extending the startup’s reach while transferring core technology. The transaction is...
FDA accelerates early US trial entry
The FDA launched an expedited investigational new drug (IND) pilot program to speed up timelines for first-in-human studies in the United States. Under “Operation Trialblazer,” the agency will...
FDA tightens scrutiny of foreign clinical trial data
The FDA signaled tighter oversight of early-stage clinical data generated outside the United States, citing concerns about regulatory capacity in host countries and the ability to conduct...
US immunology trial readout – dual-acting PD-1/VEGF approach
Akeso and Summit Therapeutics reported new overall survival results for ivonescimab (HARMONi-2), showing patients lived longer than those receiving Merck’s Keytruda in a Phase 3 lung cancer study....
Phase 3 funding for oral thyroid eye disease therapy
Sling Therapeutics raised $123 million in a Series C round to run its Phase 3 confirmatory trial for linsitinib, positioning it as an oral alternative for thyroid eye disease. The Orbit study...
Oncology licensing – GSK buys global rights to trispecific T-cell engager
GSK agreed to acquire global rights to a preclinical trispecific T-cell engager from Chimagen Biosciences in a deal worth up to $750 million. The company plans to develop the asset for multiple...
Prime assembly advances large-DNA genome integration
Prime assembly, a new genome engineering approach described in Nature, enables targeted integration of long DNA fragments into programmable genomic locations. The method uses CRISPR-targeted dual...
Neurobiology platform – xenocortical mice with human neurons
Stanford researchers reported “xenocortical mice” engineered to make space for human neurons in vivo, creating an animal model with nearly half the cortex volume replaced by human cells. The...
Cell therapy manufacturing automation deal
Cellares and GenomeFrontier Therapeutics partnered to evaluate automated manufacturing for GF-CART01 using Cellares’ Cell Shuttle platform. The collaboration focuses on translating...
Regulatory overhaul for faster US trial starts and tighter overseas scrutiny
The FDA is moving to accelerate early-stage drug development in the US while tightening oversight where trials are conducted abroad. The agency launched an Expedited Investigational New Drug (IND)...